RecruitingNot ApplicableNCT07305519

The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth:

The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in Preventing Preterm Birth: A Randomized Controlled Trial


Sponsor

University of Roma La Sapienza

Enrollment

150 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study is to assess the effect of a combination of Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in women at risk of preterm birth (PTB).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Magnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone and Standard Treatment (Guideline-Based) for people with preterm labor. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMagnesium-PEA-HMW Hyaluronic Acid-Vitamin B6-Vitamin D + Vaginal Progesterone

Participants randomized to the treatment arm will receive a combination oral supplement containing Magnesium (450 mg), Palmitoylethanolamide (200 mg), high-molecular-weight Hyaluronic Acid (200 mg), Vitamin B6 (2.6 mg), and Vitamin D (50 µg / 2000 IU), administered as two tablets per day. The supplement will be given in addition to standard vaginal progesterone (200 mg once daily). Treatment begins at enrollment (20-34 weeks' gestation) and continues until 37 weeks of gestati

OTHERStandard Treatment (Guideline-Based)

Participants randomized to the control arm will receive standard therapy consisting of vaginal progesterone (200 mg once daily) from enrollment (20-34 weeks' gestation) until 37 weeks of gestation. No additional supplements or investigational products will be administered.


Locations(1)

Policlinico Umberto I

Rome, RM, Italy

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NCT07305519


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